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The Role of Oxytocin in the Second Stage of Labor (ROSSoL)

Primary Purpose

Labor Complication

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continue Oxytocin
Discontinue Oxytocin
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Complication

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Nulliparous pregnant women >/= 37 weeks gestation
  • Singleton pregnancies
  • Admission for induction of labor or spontaneous labor

Exclusion Criteria:

  • Multiple gestations
  • Multiparous patients
  • Patients with major fetal anomalies
  • Not on oxytocin at the time of complete cervical dilation
  • Patients with fetal head visible at the perineum on diagnosis of complete cervical dilation

Sites / Locations

  • Barnes Jewish HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Discontinue Oxytocin

Continue Oxytocin

Arm Description

Outcomes

Primary Outcome Measures

Second stage duration
Time interval from complete cervical dilation to delivery of fetus

Secondary Outcome Measures

Rate of operative delivery
Rate of cesarean section and operative vaginal delivery including forcep or vacuum
Rate of Postpartum hemorrhage
Estimated blood loss >500 mL for vaginal delivery and >1000 mL for cesarean delivery
Estimated blood loss
Estimated blood loss at time of delivery (mL)
Rate of chorioamnionitis during the second stage of labor
Chorioamnionitis diagnosed at discretion of primary provider during the second stage of labor
Rate of endometritis
Postpartum endometritis as diagnosed by primary provider
Rate of severe perineal laceration
3rd or 4th degree perineal laceration
Rate of composite neonatal morbidity
1 or more of the following: death, birth injury, umbilical artery acidosis, respiratory distress, transient tachypnea, meconium aspiration with pulmonary hypertension, hypoxic-ischemic encephalopathy, hypoglycemia, hypothermia treatment, or suspected neonatal sepsis.

Full Information

First Posted
March 6, 2020
Last Updated
July 24, 2023
Sponsor
Washington University School of Medicine
Collaborators
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT04303702
Brief Title
The Role of Oxytocin in the Second Stage of Labor
Acronym
ROSSoL
Official Title
Role of Oxytocin in the Second Stage of Labor: a Randomized Controlled Trial (The ROSSoL Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.
Detailed Description
Oxytocin is widely used on Labor and Delivery units throughout the world.Laboring patients are most likely to initiate oxytocin in the first stage of labor. Among those who receive oxytocin, first stage initiation is far more common than second stage initiation. The goal of first stage administration is to increase uterine contractility and cause cervical dilation, particularly in patients who have epidural analgesia. Once complete cervical dilation has been achieved, most providers choose to continue oxytocin in the second stage of labor for the theoretic benefit of increased expulsion "power" while pushing. This practice is currently not evidence-based as the limited data thus far suggests no difference in operative deliveries with the use of oxytocin augmentation in general. The benefits and risk of oxytocin continuation in the second stage of labor is unknown. Oxytocin administration is associated with the risk of uterine tachysystole, postpartum hemorrhage,and maternal hyponatremia. These risks call for a closer look at prolonged oxytocin use past the first stage of labor. This is a randomized controlled trial investigating the utility of oxytocin administration in the second stage of labor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Discontinue Oxytocin
Arm Type
Other
Arm Title
Continue Oxytocin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Continue Oxytocin
Intervention Description
The administration and titration of oxytocin for labor augmentation is per a hospital based protocol. To summarize, oxytocin is initiated intravenously at 2 milliunits/minute and increased by 2 milliunits/minute every 20 minutes until an adequate contraction pattern is attained or a maximum of 40 millunits/minute has been achieved. This protocol for titration and administration will be applied in this study to the oxytocin group. The intravenous pumps on Labor and Delivery have automated functions for intravenous administration of oxytocin that is milliunit-based and the same routine pumps will be used in this study. The study bag will be administered per current oxytocin protocol. Since patients will already be on oxytocin at time of randomization, their current bag of oxytocin will be continued by the primary provider at a rate of their discretion.
Intervention Type
Other
Intervention Name(s)
Discontinue Oxytocin
Intervention Description
Patients will have their oxytocin discontinued in the second stage of labor. The patient will receive routine maintenance IV fluids per the discretion of the provider.
Primary Outcome Measure Information:
Title
Second stage duration
Description
Time interval from complete cervical dilation to delivery of fetus
Time Frame
During admission for delivery
Secondary Outcome Measure Information:
Title
Rate of operative delivery
Description
Rate of cesarean section and operative vaginal delivery including forcep or vacuum
Time Frame
During admision for delivery
Title
Rate of Postpartum hemorrhage
Description
Estimated blood loss >500 mL for vaginal delivery and >1000 mL for cesarean delivery
Time Frame
During admission for delivery
Title
Estimated blood loss
Description
Estimated blood loss at time of delivery (mL)
Time Frame
During admission for delivery
Title
Rate of chorioamnionitis during the second stage of labor
Description
Chorioamnionitis diagnosed at discretion of primary provider during the second stage of labor
Time Frame
During admission for delivery
Title
Rate of endometritis
Description
Postpartum endometritis as diagnosed by primary provider
Time Frame
During admission for delivery
Title
Rate of severe perineal laceration
Description
3rd or 4th degree perineal laceration
Time Frame
During admission for delivery
Title
Rate of composite neonatal morbidity
Description
1 or more of the following: death, birth injury, umbilical artery acidosis, respiratory distress, transient tachypnea, meconium aspiration with pulmonary hypertension, hypoxic-ischemic encephalopathy, hypoglycemia, hypothermia treatment, or suspected neonatal sepsis.
Time Frame
During admission for delivery

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Nulliparous pregnant women >/= 37 weeks gestation Singleton pregnancies Admission for induction of labor or spontaneous labor Exclusion Criteria: Multiple gestations Multiparous patients Patients with major fetal anomalies Not on oxytocin at the time of complete cervical dilation Patients with fetal head visible at the perineum on diagnosis of complete cervical dilation Maternal medical condition that prohibits prolonged second stage
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nandini Raghuraman, MD MSCI
Phone
9186917389
Email
nraghuraman@wustl.edud
Facility Information:
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nandini Raghuraman, MD MS
Phone
918-691-7389
Email
raghuramann@wudosis.wustl.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Role of Oxytocin in the Second Stage of Labor

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